NATURA-LAX- polyethylene glycol 3350 powder, for solution

NATURA-LAX by

Drug Labeling and Warnings

NATURA-LAX by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association, Geri-Care Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17g (cap filled to the top)

Purpose

Laxative

Uses

• relieves occasional constipation (irregularity)

• generally produces a bowel movement in 1 to 3 days

Warnings

Allergy alert: Do not use if you are allergic to polyethylene glycol

Do not use if you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if you have

• nausea, vomiting or abdominal pain
• a sudden change in bowel habits that lasts over 2 weeks
• irritable bowel syndrome

Ask a doctor or pharmacist before use if you are taking a prescription drug

When using this product you may have loose, watery, more frequent stools

Stop use and ask a doctor if

• you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition.
• you get diarrhea
• you need to use a laxative for longer than 1 week
  

If pregnant or breast feeding ask a health professional before use.

Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center right away.

Directions

• do not take more than directed unless advised by your doctor
• the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line
• adults and children 17 years of age and older:
• • fill to 17 grams line in cap for the correct dose
• • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
• • use once daily
• • use no more than 7 days
• children 16 years of age or younger: ask a doctor

Other information

• store at 20° - 25°C (68° - 77°F)
• tamper-evident: do not use if foil seal under cap printed with “SEALED for YOUR PROTECTION” is missing, open or broken.

Inactive ingredients

none

For serious adverse events call:

1-888-710-0006

Package label

NDC: 63868-002-14

Quality Choice

compare to the active ingredient in miralax

original  prescription strength

Natura-LAX

Osmotic Laxative

polyethylene glycol 3350

powder for solution

Dissolves in Any Beverage

relieves occasional constipation (irregularity)

softens stool

14 once daily doses

net wt 8.3 oz (238 g)

INGREDIENTS AND APPEARANCE

NATURA-LAX 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)	POLYETHYLENE GLYCOL 3350	17 g  in 17 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-002-14	238 g in 1 BOTTLE
2	NDC: 63868-002-30	510 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090812	05/01/2014

Labeler - Chain Drug Marketing Association (011920774)

Registrant - Geri-Care Pharmaceutical Corp (611196254)